The totally subcutaneous implantable-defibrillator (S-ICD) is a new alternative to the conventional transvenous ICD system to minimize intravascular lead complications. There are limited data ...describing the long-term performance of the S-ICD. This paper presents the first large international patient population collected as part of the EFFORTLESS S-ICD Registry.
The EFFORTLESS S-ICD Registry is a non-randomized, standard of care, multicentre Registry designed to collect long-term, system-related, clinical, and patient reported outcome data from S-ICD implanted patients since June 2009. Follow-up data are systematically collected over 60-month post-implant including Quality of Life. The study population of 472 patients of which 241 (51%) were enrolled prospectively has a mean follow-up duration of 558 days (range 13-1342 days, median 498 days), 72% male, mean age of 49 ± 18 years (range 9-88 years), 42% mean left ventricular ejection fraction. Complication-free rates were 97 and 94%, at 30 and 360 days, respectively. Three hundred and seventeen spontaneous episodes were recorded in 85 patients during the follow-up period. Of these episodes, 169 (53%) received therapy, 93 being for Ventricular Tachycardia/Fibrillation (VT/VF). One patient died of recurrent VF and severe bradycardia. Regarding discrete VT/VF episodes, first shock conversion efficacy was 88% with 100% overall successful clinical conversion after a maximum of five shocks. The 360-day inappropriate shock rate was 7% with the vast majority occurring for oversensing (62/73 episodes), primarily of cardiac signals (94% of oversensed episodes).
The first large cohort of real-world data from an International patient S-ICD population demonstrates appropriate system performance with clinical event rates and inappropriate shock rates comparable with those reported for conventional ICDs. Clinical trial registration URL: http://www.clinicaltrials.gov. Unique identifier NCT01085435.
Increasing complexity and new highly differentiated therapeutic procedures in cardiology result in a need for additional training beyond cardiology board certification. The German Cardiac Society ...therefore developed a variety of certifications of educational curricula and definition of specialized centers. Standardization and structuring in education and patient treatment, as defined by certifications may be helpful; however, introduction of certification can have serious consequences for hospital structure, the side effects of which may impair quality of treatment for individual patients. The current article discusses these issues against the background of the following questions: how is quality defined? How do certifications interfere with patient care on a nationwide level, how do they influence responsibilities and teamwork? Are there conflicts of interests by designing certifications and how good are the organizational structures? Finally, suggestions are made on what has to be considered when designing certifications. Certifications should acknowledge all cardiologists, irrespective of their position in the level of care. There should be a coherent unified concept synchronizing all certifications and administration needs to be transparent and well structured.
Indications for TF-TAVI (transfemoral transcatheter aortic valve implantation) are rapidly changing according to increasing evidence from randomized controlled trials. Present trials document the ...non-inferiority or even superiority of TF-TAVI in intermediate-risk patients (STS-Score 4–8%) as well as in low-risk patients (STS-Score < 4%). However, risk scores exhibit limitations and, as a single criterion, are unable to establish an appropriate indication of TF-TAVI vs transapical TAVI vs SAVR (surgical aortic valve replacement). The ESC (European Society of Cardiology)/EACTS (European Association for Cardio-Thoracic Surgery) guidelines 2017 and the German DGK (Deutsche Gesellschaft für Kardiologie)/DGTHG (Deutsche Gesellschaft für Thorax-, Herz- und Gefäßchirurgie) commentary 2018 offer a framework for the selection of the best therapeutic method, but the individual decision is left to the discretion of the heart teams. An interdisciplinary TAVI consensus group of interventional cardiologists of the ALKK (Arbeitsgemeinschaft Leitende Kardiologische Krankenhausärzte e.V.) and cardiac surgeons has developed a detailed consensus on the indications for TF-TAVI to provide an up-to-date, evidence-based, comprehensive decision matrix for daily practice. The matrix of indication criteria includes age, risk scores, contraindications against SAVR (e.g., porcelain aorta), cardiovascular criteria pro TAVI, additional criteria pro TAVI (e.g., frailty, comorbidities, organ dysfunction), contraindications against TAVI (e.g., endocarditis) and cardiovascular criteria pro SAVR (e.g., bicuspid valve anatomy). This interdisciplinary consensus may provide orientation to heart teams for individual TAVI-indication decisions. Future adaptations according to evolving medical evidence are to be expected.
Graphic abstract
Interdisciplinary consensus on indications for transfemoral transcatheter aortic valve implantation (TF-TAVI).
Cardiac resynchroinsation therapy (CRT) aims to correct the mechanical dyssynchrony in patients with heart failure and broad QRS complex. Until now, indication for CRT is based mainly on clinical and ...electrocardiographic criteria. Because QRS width is only weakly correlated to mechanical dyssynchrony, imaging techniques such as echocardiography and magnetic resonance tomography (MRT) seem suitable for analysis of dyssynchrony. Echocardiography has been studied in several studies for identification of suitable CRT candidates. Apart from conventional methods such as M mode-, 2 D-, and Doppler echocardiography other techniques which will be discussed in this article, including tissue Doppler echocardiography, have been used. Despite many positive results in individual studies no single echocardiographic parameter was able to predict positive CRT response in a prospective multicenter trial. Thus, QRS width remains the "gold standard" for CRT patient identification at present. In borderline cases, a combination of several echocardiographic measures of dyssynchrony may prove helpful. The results of studies with new techniques such as 2-dimensional strain analysis or 3D-echocardiography remain to be awaited. In the future, MRT may play a bigger role in this setting.
Background
Etravirine is approved for use in treatment-experienced patients at a dose of 200 mg twice daily. Efavirenz has been associated with greater increases in serum lipids compared with other ...non-nucleosides in randomized trials of first-line treatment.
Methods
In this double-blind, placebo-controlled trial, 157 treatment-naive patients with HIV RNA >5000 copies/mL were randomized 1 : 1 to either 400 mg of etravirine once daily (n = 79) or 600 mg of efavirenz once daily (n = 78) plus two nucleoside analogues (either abacavir/lamivudine, zidovudine/lamivudine or tenofovir/emtricitabine) for 48 weeks. Lipids were measured under fasting conditions at baseline and all visits to Week 48. Clinicaltrials.gov identifier: NCT00903682.
Results
Overall, the patients had a median baseline CD4 count of 302 cells/mm3 (range 74-722) and a median HIV RNA of 4.8 log10 copies/mL (range 3.5-6.6). Both the non-nucleosides and the nucleoside analogues used caused changes in serum lipids. In the efavirenz arm, patients showed significantly larger increases in high-density lipoprotein (HDL) (+0.15 mmol/L, P = 0.004), low-density lipoprotein (LDL) (+0.35 mmol/L, P = 0.005), total cholesterol (+0.61 mmol/L, P < 0.0001) and triglycerides (+0.33 mmol/L, P = 0.03) at Week 48 compared with the etravirine arm. Across the two arms, patients taking abacavir/lamivudine showed greater increases in total cholesterol (+0.47 mmol/L, P = 0.005) compared with patients taking tenofovir/emtricitabine. There were fewer grade 3/4 elevations in total cholesterol, LDL and triglycerides in the etravirine arm (2 patients, 1 patient and 0 patients, respectively) versus the efavirenz arm (8 patients, 6 patients and 2 patients, respectively).
Conclusions
In the SENSE trial, first-line treatment with 400 mg of etravirine once daily plus two nucleoside analogues led to fewer grade 3 or 4 lipid elevations compared with efavirenz plus two nucleoside analogues.
Abstract
Background
After percutaneous mitral-valve edge-to-edge repair (MVER) for mitral regurgitation (MR) in patients with baseline tricuspid regurgitation (TR), about one third of patients shows ...improvement in TR severity. It is unknown whether this improvement may depend on the presence of a right ventricular (RV) pacemaker (PM) lead.
Aim
We investigated whether the presence of an existing RV PM lead influences TR severity after successful MVER due to symptomatic secondary MR.
Methods and results
We retrospectively analyzed 115 consecutive patients with symptomatic secondary high-grade MR (age 78.1±9.4 years, 50 women (43%) and baseline TR grade > or =1 (semiquantitative grading from 0 to 5) treated with MVER using the MitraClipTM device (Abbott, Cardiovascular, USA) and separated them in 2 groups, 43 patients with a PM lead compared to 72 pts without (see Table). TR grading by echocardiography was performed before and 3 months after MVER. (median follow up duration was 3 months). Procedural success with reduction of MR to < or =2/4 grades was 100% in both groups (p<0,001 vs. baseline). There was an overall significant change in TR grade after MVER in 46 pts (p 0,032): but both increase in TR in 17 pts (16.7%, p=0.58), in 10 pts with and in 7 pts without PM lead (58.8% vs. 41.2%, respectively; p=0.84) was not significant; the decrease in TR in 29 patients (28.4%, p=0.57), in 20 pts with and in 9 pts without PM lead (69% and 31%, respectively; p=0.47) also failed to reach statistical significance. TR reduction was associated with RV dilatation at baseline (p=0.006) but not the presence of pulmonary hypertension (p=0.83).
Conclusion
There was an overall significant change in TR after successful MVER. Although there was a trend towards an increase in TR after MVER in pts with PM lead there was no overall significant correlation between changes in TR severity and the presence of an RV PM lead but rather with baseline RV dilatation.
Funding Acknowledgement
Type of funding sources: None.
Abstract
Background
In young patients suffering from hypertrophic obstructive cardiomyopathy (HOCM) surgical myectomy is still considered as the gold standard for septal reduction therapy.
Purpose
To ...assess the safety and efficacy of alcohol septal ablation (ASA) for reduction of left ventricular outflow tract gradient (LVOTG) and symptoms in HOCM patients ≤25 years.
Methods and results
All ASA procedures performed at our institution between 2002 and 2020 were retrospectively allocated to a patient group ≤25 years (group 1) and a reference group >25 years (group 2). Patients were evaluated at baseline and chronic follow-up (FU) after 6 months. 1,264 procedures were analysed in group 2 (58.6±13.5 years) and 41 procedures in group 1 (20.9±3.3 years). Proportion of family history of sudden cardiac death was higher in group 1 (56.1% vs. 24.6% in group 2; p<.0001). We more often found a previously implanted cardiac device in group 1 (31.7% vs. 9.0% in group 2; p<.0001) and the interventricular septal diameter (IVSD) was higher in young patients at baseline (26.0±6.5 mm vs. 21.3±4.4 mm in group 2; p<.0001). LVOTG at baseline did not differ between the groups (54.4±24.4 mmHg in group 1 vs. 52.4±36.6 mmHg in group 2 (p=n.s.). Relief of symptoms was shown for both groups at FU compared to baseline (group 1: mean NYHA class 2.5 at baseline and 1.3 at FU; p<.0001; group 2: mean NYHA class 2.7 at baseline and 1.4 at FU; p<.0001). Compared to baseline IVSD was significantly reduced at FU (20.3±8.2 mm in group 1 at FU; 16.8±5.7 mm in group 2 at FU; p<.0001 for each group compared to baseline). LVOTG improved significantly during FU (25.5±20.0 mmHg in the young patients; 22.1±21.7 mmHg in the reference group; p<.0001 for each group compared to baseline). Mortality was 0.0% in patients ≤25 years and 0.9% in the reference group.
Conclusion
Our data demonstrate safety and efficacy of ASA to improve LVOT obstruction and symptoms in young adults and adolescents (14–25 years) suffering from symptomatic HOCM. Therefore, ASA may be considered also for this patient population. However, these results may only hold for experienced centres and, thus, invasive procedures in young patients should be reserved to centres with the required expertise.
Funding Acknowledgement
Type of funding sources: None. Table 1. Baseline characteristics. ASA = alcohol septal ablation. ICD = implantable cardioverter-defibrillator. IVSD= interventricular septum diameter. LA = left atrium. LVOTG = left ventricular outflow tract gradient. n.s. = not significant. PM = pacemaker. SCD = sudden cardiac death. SM = septal myectomy.Figure 1. Echocardiographic parameters in patients ≤25 years at baseline and follow-up (FU) 6 months after alcohol septal ablation. ***p<.0001. A. Interventricular septum diameter (IVSD). B. Left ventricular outflow tract gradient (LVOTG).
Background
Cardiac resynchronisation therapy (CRT) reduces morbidity and mortality in appropriately selected patients with heart failure and is strongly recommended for such patients by guidelines. A ...European Society of Cardiology (ESC) CRT survey conducted in 2008–2009 showed considerable variation in guideline adherence and large individual, national and regional differences in patient selection, implantation practice and follow‐up. Accordingly, two ESC associations, the European Heart Rhythm Association and the Heart Failure Association, designed a second prospective survey to describe contemporary clinical practice regarding CRT.
Methods and results
A survey of the clinical practice of CRT‐P and CRT‐D implantation was conducted from October 2015 to December 2016 in 42 ESC member countries. Implanting centres provided information about their hospital and CRT service and were asked to complete a web‐based case report form collecting information on patient characteristics, investigations, implantation procedures and complications during the index hospitalisation. The 11 088 patients enrolled represented 11% of the total number of expected implantations in participating countries during the survey period; 32% of patients were aged ≥75 years, 28% of procedures were upgrades from a permanent pacemaker or implantable cardioverter‐defibrillator and 30% were CRT‐P rather than CRT‐D. Most patients (88%) had a QRS duration ≥130 ms, 73% had left bundle branch block and 26% were in atrial fibrillation at the time of implantation. Large geographical variations in clinical practice were observed.
Conclusion
CRT Survey II provides a valuable source of information on contemporary clinical practice with respect to CRT implantation in a large sample of ESC member states. The survey permits assessment of guideline adherence and demonstrates variations in patient selection, management, implantation procedure and follow‐up strategy.
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